Optic Disk DrusenNCT03957642
Systematic Imaging Examination in ODD
An observational study of Optic Disk Drusen, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
To evaluate the diagnostic value of systematic ophthalmologic imaging examination in the diagnosis of embedded optic disc drusen (ODD) in adolescents with mild visual impairment. Read more about this study
- Who is it for?
- Ages 14 to 28 years
- Conditions the study is for
- Optic Disk Drusen
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2019to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents with mild visual impairment accompanied by disc flushing, crowded optic disc, and a blurred disc halo.
Who may be able to join
- Male or female.
- Age 14-28.
- The results of visual acuity examination suggest mild visual impairment.
- The results of ophthalmologic examination showed that the blurred degree of the local boundary of the optic disc was different and the optic disc was congested.
Who cannot join
- patients with amblyopia.
- patients with neurological disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The third affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Xiang Zhu, Doctor, 13826452564, 0628zhuxiang@163.com
About this study
Official title: Diagnostic Value of Systematic Imaging Examination in Embedded Optic Disc Drusen in Adolescents With Mild Visual Impairment
To evaluate the diagnostic value of systematic ophthalmologic imaging examination in the diagnosis of embedded optic disc drusen (ODD) in adolescents with mild visual impairment.
Read the detailed description
Patients are evaluated through optometric examination, fundus photography, visual field examination, OCT, US, and FFA.
- Conditions
- Optic Disk Drusen
- Medical subject headings
- Optic Disk Drusen
What is being measured
The primary outcome is the main question the study is designed to answer.
detection rate of embedded ODD
detection rate of embedded ODD
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start21 May 2019
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Disk DrusenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Zhu, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xiuhua Jia, Dorctor, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957642
- Sponsor's protocol ID
- Systematic Imaging Examination
- Status last verified
- May 2019
- First submitted
- 19 May 2019
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Systematic Imaging Examination in Embedded Optic Disc Drusen in Adolescents With Mild Visual Impairment
- ClinicalTrials.gov ID
- NCT03957642
- Acronym / sponsor ID
- Systematic Imaging Examination
- Conditions
- Optic Disk Drusen
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 21 May 2019 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the diagnostic value of systematic ophthalmologic imaging examination in the diagnosis of embedded optic disc drusen (ODD) in adolescents with mild visual impairment.
Detailed description
Patients are evaluated through optometric examination, fundus photography, visual field examination, OCT, US, and FFA.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with mild visual impairment accompanied by disc flushing, crowded optic disc, and a blurred disc halo.
Key inclusion criteria (4 listed)
- Male or female.
- Age 14-28.
- The results of visual acuity examination suggest mild visual impairment.
- The results of ophthalmologic examination showed that the blurred degree of the local boundary of the optic disc was different and the optic disc was congested.
Key exclusion criteria (2 listed)
- patients with amblyopia.
- patients with neurological disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
detection rate of embedded ODD
Time frame: 1 week
detection rate of embedded ODD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
Related trials for Optic Disk Drusen
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Optic Nerve Head Evaluation Through Multimodal Blood Flow Analysis: a Prospective Observational, Multi-center Study
Neuro-Ophthalmology, Optic Neuropathies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuhua Jia, Dorctor principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optic Disk Drusen, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Zhu, Doctor (13826452564, 0628zhuxiang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection rate of embedded ODD (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.